a study of bcma-directed car-t cells treatment in subjects with r/r multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a single-center, non-randomized study to evaluate the safety and efficacy of c-car088 in relapsed or refractory multiple myeloma patients.

the study will include the following sequential phases: screening, apheresis, baseline, pre-treatment (cell product preparation, lymphodepleting chemotherapy), c-car088 infusion and follow-up visit.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, male or female; 2. the patient volunteered to participate in the study, and he or his legal guardian signed the informed consent; 3. patients with a clear diagnosis of relapsed or refractory multiple myeloma 4. the patient have one or more measurable multiple myeloma lesion, must include one of the following conditions: * serum m protein≥1.0 g/dl(10g/l) * urine m protein≥200 mg/24h * serum free light chain(sflc): κ/λ flc ratio is abnormal and affected flc ≥10mg / dl 5. bone marrow sample is confirmed as bcma-positive by flow cytometry or pathological examination; 6. at least 2 weeks from monoclonal antibody therapy prior to car t cell therapy. 7. ecog scores 0 - 1; 8. good cardiac and pulmonary organ function; 9. expected survival time \> 12 weeks;. 10. female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study. exclusion criteria: 1. have a history of allergy to cellular products; 2. laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum alt or ast is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin \<80g / l; absolute neutrophil count \<1000 / mm3 or dependent on gcsf or other growth factors can maintain the centriole count ≥1000 / mm²; platelet count \<50000 / mm³ or the above level can be maintained due to platelet transfusion; 3. presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function grade 3 (moderate) or grade 4 (severe) heart disease (according to the new york heart association function classification method: nyha); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment; 4. a history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease; 5. need to use any anticoagulant (except aspirin); 6. patients requiring urgent treatment due to tumor progression or spinal cord compression; 7. patients with cns metastasis or symptoms of cns involvement; 8. after allogeneic hematopoietic stem cell transplantation; 9. plasma cell leukemia; 10. patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents; 11. uncontrolled active infection; 12. have used any car t cell products or other genetically modified t cell therapy before; 13. hepatitis b or hepatitis c virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to hiv infected persons; 14. have a history of alcoholism, drug addiction and mental illness; 15. participated in any other clinical trial within 1 months; 16. the investigators believe that there are other circumstances that are not suitable for the trial.

Keywords: multiple myeloma